AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
1 other identifier
interventional
88
3 countries
8
Brief Summary
The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Aug 2006
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 13, 2014
August 1, 2014
11 months
September 5, 2006
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess tumor growth
assessed every 12 weeks
Secondary Outcomes (1)
Assess safety and tolerability of AZD6244
assessed at each visit
Study Arms (2)
1
ACTIVE COMPARATORPemetrexed
2
EXPERIMENTALAZD6244
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with non-small cell lung cancer
- Previously received one or two chemotherapeutic treatments
You may not qualify if:
- Previous therapy with MEK inhibitor or pemetrexed
- Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Los Angeles, California, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Cluj-Napoca, Romania
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emerging Oncology Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
August 1, 2006
Primary Completion
July 1, 2007
Study Completion
December 1, 2008
Last Updated
August 13, 2014
Record last verified: 2014-08